Associate Director, Regulatory Affairs
Virtual Vocations Inc, New York, NY, United States
A company is looking for an Associate Director, Regulatory Affairs CMC and Devices.
Key Responsibilities:
Plan and coordinate global regulatory submissions, ensuring high-quality, compliant documentation for clinical programs Independently author and compile Module 2 and Module 3 content, including technical reports and stability summaries Prepare responses to CMC and device-related questions from global regulatory agencies and support health authority interactions
Required Qualifications:
Bachelor's degree with a minimum of 6+ years of experience in CMC regulatory affairs for clinical-stage biologics Hands-on authoring experience for late-stage IND submissions and amendments Proven experience preparing responses to health authority questions related to CMC and device topics Strong understanding of global CMC regulatory requirements and guidelines Experience with biologics and drug-device combination products; familiarity with companion diagnostics is a plus
Plan and coordinate global regulatory submissions, ensuring high-quality, compliant documentation for clinical programs Independently author and compile Module 2 and Module 3 content, including technical reports and stability summaries Prepare responses to CMC and device-related questions from global regulatory agencies and support health authority interactions
Required Qualifications:
Bachelor's degree with a minimum of 6+ years of experience in CMC regulatory affairs for clinical-stage biologics Hands-on authoring experience for late-stage IND submissions and amendments Proven experience preparing responses to health authority questions related to CMC and device topics Strong understanding of global CMC regulatory requirements and guidelines Experience with biologics and drug-device combination products; familiarity with companion diagnostics is a plus